Fish Collagen Peptide Food Supplement on Weight and Body Composition

Not Applicable

Completed

• Conditions: Food Complement; Weight Management
• Interventions: Dietary Supplement: Naticol supplement; Dietary Supplement: Placebo supplement

• Registration Number: NCT03872297
• Lead Sponsor: Institut Pasteur de Lille

Brief Summary

Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and humans.

However, very few studies investigated the effect of fish collagen peptides on weight, body composition or glycemic response. Recently, it has been shown that the consumption of fish collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model made obese by a hyperlipidic diet. Since these results have never been observed in humans, this pilot study proposes to answer this question.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-14
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Men in overweight (BMI between 25kg/m² and 30kg/m²)
• Aged from 18 and 60 years
• Having signed the informed consent form;
• Susceptible to follow the constraints generated by the study;

Exclusion Criteria

• Subject treated for type 1 or 2 diabetes, or for any other metabolic disorder (severe dyslipidemia: TG> 3 g / L and total cholesterol> 2.5 g / L);
• Subject with untreated and uncorrected high blood pressure;
• Subject with untreated or uncorrected dysthyroidism by drug therapy;
• Subject with a serious general illness that may prevent his or her ability to complete the trial or that could bias the results of the study;
• Subject consuming antibiotic treatment in the month prior to inclusion;
• Subject treated with steroidal anti-inflammatory drugs, anabolic steroids, anticoagulants or corticosteroids;
• Subject knowing allergy to fish or fish collagen;
• Subject taking any dietary supplement or drug that may interact with the results of the study or that could alter the bioavailability of the product under study;
• Subject following or having followed a low-calorie diet (energy intake <1500 kcal / day) in the 3 months preceding inclusion and / or likely to undertake this diet during the test;
• Subject having lost more than 5% of his initial weight during the last 3 months;
• Subject following a special diet: eg. vegetarian, macrobiotic diet, high protein diet;
• Subject with diagnosed eating disorders (anorexia, bulimia);
• Subject with gastrointestinal malabsorption such as celiac disease, Crohn's disease or lactose intolerance;
• Subject having undergone bariatric surgery;
• Subject with excessive alcohol consumption at more than 3 drinks a day ;
• Subject planning to modify his tobacco consumption (eg weaning) or his level of physical activity (significant increase) before the end of the intervention period;
• Subject having an aversion to the grapefruit aroma;
• Subject unable to understand or adhere to the protocol;
• Subject participating in another clinical study or exclusion period from another study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naticol supplement	Naticol supplement	Consumption of the active food complement during 3 months containing Naticol.
Placebo supplement	Placebo supplement	Consumption of a non active food complement during 3 months.

Primary Outcome Measures

Name	Time	Method
Weight of participants	0 and 3 months	Weight is expressed in kilograms

Secondary Outcome Measures

Name	Time	Method
Insulin level in plasma	0 and 3 months	Data are expressed in μU/ml
Body composition par DXA analysis	0 and 3 months	Fat mass is expressed in kg and percent, muscle mass in kg and percent.
Body mass index	0 and 3 months	kg/m²
Waist circumference	0 and 3 months	Data are expressed in centimeters
Physical activity intensity	0 and 3 months	Score obtained via Ricci and Gagnon questionnaire. The questionnaire contains 9 questions ; score could be between 9 and 45 points.; * under 18 points : inactive behavior; * between 19 and 35 points : active behavior; * over 35 points : very active behavior
Pro-inflammatory cytokines concentration	0 and 3 months	Assay for TNFalpha, IL-1beta and IL-6 in plasma
Lipid profile in plasma	0 and 3 months	Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides. Data are expressed in g/L and in mmol/L
Glycemia level in plasma	0 and 3 months	Data are expressed in g/L and mmo/L
Microbiota analysis	0 and 3 months	Rate comparison of different bacteria families
HOMA index	0 and 3 months	This index indicates the insulin resistance and was calculated as follow : HOMA \[(glycémie mmol/l X insulinémie μU/ml) à jeun / 22,5\]
Height	0	centimeters

Trial Locations

Locations (1)

NutrInvest - Institut Pasteur de Lille; 🇫🇷 Lille, Nord, France